Recall Z-1239-06 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Aksys, Ltd.
Aksys PHD Personal Hemodialysis System for daily home hemodialysis; an automated high permeability hemodialysis system, water purification system for hemodialysis; Manufactured in the USA for Aksys Ltd., Lincolnshire, IL 60069 USA; Model 1M101
| Date | Jul 13, 2006 (initiated Jun 26, 2006) |
| Status | Terminated |
| Reason | The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed. |
| Root cause | Other |
| Action | Aksys sent a Clinical Bulletin: Field Correction Recall, CB Number: 048, dated 6/26/2006, via overnight Federal Express to all clinics or patients currently using the PHD instrument. CB #048 advises patients that until field modifications to the PHD System can be performed to limit the maximum treatment time to 170 minutes, Aksys recommends that users not exceed this treatment time in the interim. Each user was requested to contact his/her clinic to discuss how this change may affect treatment options and to complete and mail an enclosed pre-paid, self-addressed receipt acknowledgement card. |
| Quantity | 133 units |
| Distribution | Nationwide (California, Connecticut, Florida, Georgia, Illinois, Maryland, Massachusetts, Michigan, Ohio, Nebraska, New Jersey, New York, Tennessee, Texas, Virginia, Washington and Wisconsin), and internationally to the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010131 | PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB Aksys, Ltd., Mar 26, 2002 |